2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC964
Submitter : Mr. Jason Halbert Date & Time: 10/27/2005 09:10:27
Organization : Mr. Jason Halbert
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
No
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
NO
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I don't know, isn't this a question for the FDA?
C. If so, would a rulemaking on this issue help dispet that confusion?
Ibid.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
Of course.
B. If it could, would it be able to do so as practical matter and, if so, how?
It is not up to me as an individual consumer to figure out how the FDA should enforce its own regulations. It is up to me as a consumer to follow the regulations. But this seems like a no-brainer to me. We already have alcohol, tobacco, etc. They are legal for some and not for others. It is regulated and controlled and enforced. It's not hard. A pharmacy can place the OTC stuff in full view and the staff just needs to know that like
cigarettes or tobacco or beer (all available over the counter) there is an age-restriction.

3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
Huh? Of course. Root beer comes in a brown bottle and from a distance looks exactly like real beer from a packaging perspective.

What are you talking about?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
No circumstances.
GENERAL
GENERAL
Stop the delay, please approve emergency constraception (PLAN B) IMMEDIATELY. It should be over the counter without restrictions for anyone. If a woman can get pregnant she should be able to take EC. Period. Get on with it.